Nctid:
NCT00002406
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019469", "term"=>"Indinavir"}], "ancestors"=>[{"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Cholangiocarcinoma", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>350}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-06", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["HIV-1", "Dose-Response Relationship, Drug", "HIV Protease Inhibitors", "Indinavir", "RNA, Viral", "Reverse Transcriptase Inhibitors"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).", "detailedDescription"=>"In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:\n\nArm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Documented HIV-1 seropositive status.\n* CD4 count greater than 100 cells/mm3.\n* Parental consent for patients under 18."}, "identificationModule"=>{"nctId"=>"NCT00002406", "briefTitle"=>"A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)", "orgStudyIdInfo"=>{"id"=>"246P"}, "secondaryIdInfos"=>[{"id"=>"MK-0639"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"1917 Research Clinic", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente / Infectious Disease", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Tower ID Med Associates", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"95814", "city"=>"Sacramento", "state"=>"California", "country"=>"United States", "facility"=>"Ctr for AIDS Research / Education and Service (CARES)", "geoPoint"=>{"lat"=>38.58157, "lon"=>-121.4944}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp / UCSF AIDS Program", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"HIV Clinical Research", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Ponce de Leon Ctr", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian St Lukes Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"20889", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"Natl Naval Med Ctr / Special Immunology Clinic", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}, {"zip"=>"02115", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Brigham and Women's Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston Med Ctr / Clinical Research Office", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Univ Health Ctr 7D", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"64111", "city"=>"Kansas City", "state"=>"Missouri", "country"=>"United States", "facility"=>"Kansas City Free Health Clinic", "geoPoint"=>{"lat"=>39.09973, "lon"=>-94.57857}}, {"zip"=>"08103", "city"=>"Camden", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Education & Research Building", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"08043", "city"=>"Voorhees", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Garden State Infectious Diseases / E I P Kennedy Health Sys", "geoPoint"=>{"lat"=>40.48122, "lon"=>-74.48321}}, {"zip"=>"12208", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Albany Med College / Div of HIV Medicine", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Science Ctr at Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11355", "city"=>"Flushing", "state"=>"New York", "country"=>"United States", "facility"=>"New York Hosp of Queens / AIDS Ctr", "geoPoint"=>{"lat"=>40.76538, "lon"=>-73.81736}}, {"zip"=>"10001", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"CRIA", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"St Vincents Hosp and Med Ctr / Div of HIV Med", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Anderson Clinical Research", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"44304", "city"=>"Akron", "state"=>"Ohio", "country"=>"United States", "facility"=>"Akron City Hospital", "geoPoint"=>{"lat"=>41.08144, "lon"=>-81.51901}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Thomas Jefferson Univ", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"15213", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Anderson Clinical Research", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"zip"=>"77098", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Clinical Research Network / Southhampton Med Group", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"84132", "city"=>"Salt Lake City", "state"=>"Utah", "country"=>"United States", "facility"=>"Univ of Utah School Of Medicine / Div of Infec Disease", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Merck Sharp & Dohme LLC", "class"=>"INDUSTRY"}}}}
